Sitryx advances development of PKM2 modulator SYX-5219 into atopic dermatitis patients following clinical evidence of immunomodulatory activity
- First-in-class, oral PKM2 modulator, SYX-5219, has the potential to rebalance immune function and drive sustained disease remission
- Results from completed Phase 1a trial in healthy volunteers showed SYX-5219 was safe and well tolerated with predictable pharmacology and robust target engagement
- Additionally, a dose-dependent reduction in TARC, a well-established biomarker of type 2 inflammation, was demonstrated
- First patients with atopic dermatitis have been dosed in the Phase 1b clinical trial with data anticipated by year end
Oxford, UK and Boston, MA – January 26, 2026 – Sitryx Therapeutics (“Sitryx” or “the Company”), a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease, has advanced its lead clinical program, SYX-5219, into Ph1b clinical development following analysis of data in healthy volunteers supporting the candidate’s differentiated immunomodulatory profile.
SYX-5219 is a first-in-class, oral pyruvate kinase M2 (PKM2) modulator with the potential to drive sustained disease remission in atopic dermatitis, the most common chronic inflammatory skin disease affecting over 200 million patients worldwide.
A recently completed Phase 1a clinical trial conducted in healthy volunteers in the UK demonstrated SYX-5219 was safe and well tolerated with predictable pharmacokinetics and robust target engagement. In addition, a robust dose-dependent reduction in CCL17/thymus and activation-regulated chemokine (TARC) levels was demonstrated. TARC is an established biomarker of type 2 inflammation and has been shown to correlate with disease activity and treatment response in atopic dermatitis across multiple clinical programs. The safety and pharmacology data, as well as the observed TARC reduction, provide biological evidence supporting SYX-5219’s proposed mechanism of action.
A Phase 1b clinical trial evaluating SYX-5219 in adults with moderate to severe atopic dermatitis has now commenced with the first patients successfully dosed. This trial will investigate the safety, tolerability and initial efficacy of SYX-5219 in up to 45 adult patients in the United States and Europe. The Company expects to receive data from the trial by year end. A KLH antigen-challenge study in healthy volunteers is also underway, to assess early immune response signals.
Ravi Rao, Chief Medical Officer of Sitryx, said: “A daily oral treatment to rebalance immune function and deliver durable disease remission would be transformative for the treatment of atopic dermatitis. Our latest clinical data for SYX-5219, particularly the strong reduction in the highly disease-relevant Type 2 inflammation biomarker TARC, give us further confidence in the candidate’s differentiated profile. We look forward to the progression of our Phase 1b trial, which is expected to show the first evidence of SYX-5219’s mechanistic and clinical activity in patients and guide the next stages of development.”
Alan Irvine, MD, DSc, Professor of Dermatology at Trinity College Dublin, Ireland, President of the International Eczema Council, and the trial’s Principal Investigator, said: “Moderate to severe atopic dermatitis has an enormous impact on the quality of life of people living with the condition and of those around them. There remains a significant unmet need for therapies that can bring patients relief, particularly around itch and sleep. The science behind PKM2 modulation as a target for atopic dermatitis therapy is compelling; new biomarker data from the Phase 1a study align with pre-clinical data on SYX-5219 showing reduction of inflammatory markers and drivers of itch, and enhancement of repair of the skin barrier, all supporting its potential as a novel, disease-modifying approach in atopic dermatitis.”
PKM2 is a key enzyme in the central glycolytic metabolic pathway. It has been shown to be upregulated in inflamed tissues and is overexpressed in immune cell infiltrate and in keratinocytes in atopic dermatitis compared to healthy skin. By modulating PKM2, SYX-5219 alters T lymphocyte and mast cell function, representing a differentiated broad, immunomodulatory, anti-itch and pro-barrier repair profile that could potentially drive sustained disease remission.
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For more information about Sitryx please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Evi Useh
+44 (0)20 3709 5700
Sitryx@icrhealthcare.com
About Sitryx
Sitryx is a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease. The Company has a broad pipeline of novel small molecule candidates targeting major autoimmune indications with high unmet need. Its lead candidate, SYX-5219, is a potentially first-in-class PKM2 modulator in development for atopic dermatitis as a once-daily oral therapy with future development potential across multiple autoimmune diseases.
Established with seed funding from SV Health Investors, Sitryx has an international syndicate of specialist investors including SV Health Investors, Sofinnova Partners, Oxford Science Enterprises, Longwood Fund, Eli Lilly and Company, and GSK.
Sitryx is headquartered in Oxford, UK with additional presence in Boston, MA. For more information, please visit www.sitryx.com.
